NCT02332811

An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients

An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic Chronic Kidney Disease Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis Secondary Objective: Evaluate the safety on the basis of adverse events, changes in laboratory values and vital signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)

Detailed description

10 weeks including, 2 weeks wash-out period and 8 weeks study treatment period

Conditions

• Renal Failure Chronic

Interventions

Type	Name	Description
DRUG	sevelamer carbonate 800mg	Pharmaceutical form:tablet Route of administration: oral
DRUG	sevelamer carbonate 2.4 g	Pharmaceutical form:powder Route of administration: oral

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2015-01-07
• Last updated: 2016-12-23

Locations

1 site across 1 country: Russia